510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2011
DEVICE: DURAFIBER AG
SMITH & NEPHEW, INC 510(k) NO: K103793(TRADITIONAL)
ATTN: TERRY MCMAHON PHONE NO : 727 392 1261
970 LAKE CARILLON DRIVE, SUITE 110SE DECISION MADE: 02-MAY-11
ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEBSTER DUO-DECAPOLAR CATHETER
BIOSENSE WEBSTER, INC. 510(k) NO: K101991(TRADITIONAL)
ATTN: BALAKA DAS PHONE NO : 909 839 8599
3333 DIAMOND CANYON RD. SE DECISION MADE: 02-MAY-11
DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K102191(ABBREVIATED)
ATTN: LEO WANG PHONE NO : 086 288 6083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 02-MAY-11
CHENGDU CH 610041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DILON 6800 ACELLA (ACELLA)
DILON TECHNOLOGIES, INC. 510(k) NO: K110384(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035
P.O. BOX 560 SE DECISION MADE: 03-MAY-11
STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: READY VIEW
GE HEALTHCARE (GE MEDICAL SYSTEMS 510(k) NO: K110573(TRADITIONAL)
ATTN: ELIZABETH MATHEW PHONE NO : 262 521 6658
3200 N GRANDVIEW BLVD, W-827 SE DECISION MADE: 03-MAY-11
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
BIOMET SPORTS MEDICINE 510(k) NO: K110039(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574 371 1176
56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 03-MAY-11
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR+BRILLIANT LASER SYSTEM
SOLTA MEDICAL, INC. 510(k) NO: K110349(TRADITIONAL)
ATTN: KRISTINE FOSS PHONE NO : 510 780 4657
25881 INDUSTRIAL BLVD. SE DECISION MADE: 03-MAY-11
HAYWARD CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
ROCHE DIAGNOSTICS 510(k) NO: K110446(TRADITIONAL)
ATTN: MICHELLE LEE NEFF PHONE NO : 317 521 2000
9115 HAGUE ROAD SE DECISION MADE: 03-MAY-11
INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
CORIN USA 510(k) NO: K110087(TRADITIONAL)
ATTN: LUCINDA GERBER PHONE NO : 813 977 4469
10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 03-MAY-11
TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
NANOTHERAPEUTICS, INC. 510(k) NO: K110976(SPECIAL)
ATTN: DENNIS TOMISAKA PHONE NO : 386 462 9663
13859 PROGRESS BLVD, SUITE 300 SE DECISION MADE: 03-MAY-11
ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICON ADULT MANUAL
ICON WHEELCHAIRS INC 510(k) NO: K110985(TRADITIONAL)
ATTN: TOM HORTON PHONE NO : 413 584 4491
115 BRIDGE STREET SE DECISION MADE: 03-MAY-11
NORTHAMPTON MA 01060 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PICCOLO COMPOSITE NAILING SYSTEM
CARBOFIX ORTHOPEDICS LTD. 510(k) NO: K111056(SPECIAL)
ATTN: YAEL RUBIN PHONE NO : 972 995 11511
11 HA'HOSHLIM STREET SE DECISION MADE: 03-MAY-11
HERZELIYA IS 46724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER C. DIFFICILE GDH
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K110620(TRADITIONAL)
ATTN: SUSAN BOGAR PHONE NO : 513 271 3700
3471 RIVER HILLS DR. SE DECISION MADE: 03-MAY-11
CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINNITUS SOUND GENERATOR MODULE
GN RESOUND A/S 510(k) NO: K110932(SPECIAL)
ATTN: LARS HAGANDER PHONE NO : 45 457 51111
LAUTRUPBJERG 7 SE DECISION MADE: 03-MAY-11
BALLERUP DA 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC MALE ADAPTER
BIOMET TRAUMA (AKA EBI LLC) 510(k) NO: K102843(SPECIAL)
ATTN: MARGARET F CROWE PHONE NO : 973 299 9300
100 INTERPACE PARKWAY SE DECISION MADE: 03-MAY-11
PARISPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSILASER PAD-IQ
VASAMED, INC. 510(k) NO: K110438(ABBREVIATED)
ATTN: GARY J SYRING PHONE NO : 608 877 2635
800 LEVANGER LANE SE DECISION MADE: 04-MAY-11
STOUGHTON WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICK UP
VOCO GMBH 510(k) NO: K110440(TRADITIONAL)
ATTN: DR. T. GERKENSMEIER PHONE NO : 494 721 719200
ANTON-FLETTNER-STR. 1-3 SE DECISION MADE: 04-MAY-11
CUXHAVEN GM 27472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFYMETRIX GENE PROFILING REAGENTS
AFFYMETRIX, INC. 510(k) NO: K103112(TRADITIONAL)
ATTN: MAUREEN MENDE PHONE NO : 650 730 5020
3 LAGOON DRIVE SUITE 160 SE DECISION MADE: 04-MAY-11
REDWOOD SHORES CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K102324(TRADITIONAL)
ATTN: SARAH HOLTGREWE PHONE NO : 901 867 4476
5677 AIRLINE RD. SE DECISION MADE: 04-MAY-11
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K102681(TRADITIONAL)
ATTN: MATTHEW GEA PHONE NO : 914 524 2099
511 BENEDICT AVE. SE DECISION MADE: 04-MAY-11
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
GENOSS CO., LTD. 510(k) NO: K102307(TRADITIONAL)
ATTN: EUNKYUNG SON PHONE NO : 714 895 7278
11075 KNOTT AVE., SUITE A SE DECISION MADE: 04-MAY-11
CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
MEDTRONIC INC. 510(k) NO: K103764(TRADITIONAL)
ATTN: YUKIKO CORSON PHONE NO : 763 526 3409
8200 CORAL SEA ST NE SE DECISION MADE: 04-MAY-11
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARDYCHROM MRSA
HARDY DIAGNOSTICS 510(k) NO: K102922(TRADITIONAL)
ATTN: RENE CLASEN PHONE NO : 805 346 2766
1430 WEST MCCOY LN. SE DECISION MADE: 04-MAY-11
SANTA MARIA CA 93455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HLS KNEETEC SYSTEM
TORNIER 510(k) NO: K094013(SPECIAL)
ATTN: SEVERINE BONNETON PHONE NO : 003 347 6613500
161 RUE LAVOISIER SE DECISION MADE: 05-MAY-11
MONTBONNOT, SAINT-ISMIER FR 383510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELYX LUTING PLUS AUTOMIX
3M ESPE DENTAL PRODUCTS 510(k) NO: K111185(TRADITIONAL)
ATTN: BERNARDO MEDELLIN, J.D. PHONE NO : 651 733 5718
3M CENTER, BUILDING 260-2A-11 SE DECISION MADE: 05-MAY-11
ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IE-ZEN (IN CLEAR SERIES HEARING AID)
WIDEX USA 510(k) NO: K110973(SPECIAL)
ATTN: FRANCIS KUK PHONE NO : 630 245 0025
2300 CABOT DRIVE, SUITE 415 SE DECISION MADE: 05-MAY-11
LISLE IL 60532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN
INTERACOUSTICS A/S 510(k) NO: K103760(TRADITIONAL)
ATTN: ERIK NIELSEN PHONE NO : 456 371 3555
DREJERVAENGET 8 SE DECISION MADE: 05-MAY-11
ASSENS DA DK-5610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENODYNE V810
MICROTEK MEDICAL, INC. 510(k) NO: K110358(TRADITIONAL)
ATTN: TOM BONNER PHONE NO : 888 844 0988
602 LEHMBERG RD. SE DECISION MADE: 05-MAY-11
COLUMBUS MS 39702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISSYS LP SPINAL FIXATION SYSTEM
CUSTOM SPINE, INC. 510(k) NO: K111099(SPECIAL)
ATTN: SAAD ATTIYAH PHONE NO : 973 265 5036
1140 PARSIPPANY BLVD. SUITE 201 SE DECISION MADE: 05-MAY-11
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
MCKESSON INFORMATION SOLUTIONS LLC510(k) NO: K102263(TRADITIONAL)
ATTN: STEVEN B DATLOF PHONE NO : 267 675 4613
1835 MARKET ST. 29TH FLOOR SE DECISION MADE: 05-MAY-11
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL 510(k) NO: K110549(TRADITIONAL)
ATTN: DONNA R LUNAK PHONE NO : 651 756 2944
ONE ST JUDE MEDICAL DRIVE SE DECISION MADE: 05-MAY-11
ST PAUL MN 55117 9913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRICITY PACS
GE HEALTHCARE 510(k) NO: K110875(TRADITIONAL)
ATTN: CHERYL BORK PHONE NO : 847 277 6038
540 W. NORTHWEST HIGHWAY SE DECISION MADE: 05-MAY-11
BARRINGTON IL 60010 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
HOWMEDICA OSTEONICS CORP 510(k) NO: K103835(TRADITIONAL)
ATTN: AVITAL MERL-MARGULIES PHONE NO : 201 831 6365
325 CORPORATE DR. SE DECISION MADE: 05-MAY-11
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
GLOBUS MEDICAL INC. 510(k) NO: K110963(SPECIAL)
ATTN: KELLY J BAKER, PH.D PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 05-MAY-11
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OWL RF PROBES
DIROS TECHNOLOGY, INC. 510(k) NO: K110593(SPECIAL)
ATTN: GEORGE DARMOS PHONE NO : 905 415 3440
232 HOOD ROAD SE DECISION MADE: 05-MAY-11
MARKHAM, ONTARIO CA L3R 3K8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOVISION
HAAS SOFTWARE 510(k) NO: K111102(TRADITIONAL)
ATTN: DAVID L STARK PHONE NO : 415 888 3700
38 MILLER AVENUE PMB 170 SE DECISION MADE: 05-MAY-11
MILL VALLEY CA 94941 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
MICROPHAGE, INC. 510(k) NO: K102342(TRADITIONAL)
ATTN: DREW SMITH PHONE NO : 303 652 5049
2400 TRADE CENTRE AVENUE SE DECISION MADE: 05-MAY-11
LONGMONT CO 80503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
SEPPIM S.A.S. 510(k) NO: K100263(TRADITIONAL)
ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174
21720 23RD DR SE SUITE 150 SE DECISION MADE: 06-MAY-11
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIC INSTRUMENT PROCESSING SYSTEM
LANGFORD IC SYSTEMS, INC. 510(k) NO: K101158(TRADITIONAL)
ATTN: TERRY LANGFORD PHONE NO : 520 745 6201
310 S. WILLIAMS BLVD. SUITE 270 SE DECISION MADE: 06-MAY-11
TUCSON AZ 85711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LUNAR VISCERAL FAT SOFTWARE
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K103730(TRADITIONAL)
ATTN: CHRIS PAULIK PHONE NO : 262 548 2010
3030 OHMEDA DRIVE SE DECISION MADE: 06-MAY-11
MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
COOK UROLOGICAL, INC. 510(k) NO: K102141(TRADITIONAL)
ATTN: CINDY FOOTE PHONE NO : 812 829 4891
1100 WEST MORGAN ST. SE DECISION MADE: 06-MAY-11
SPENCER IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX MEDICAL WIZARD SERIES CPAP MASK
APEX MEDICAL CORP. 510(k) NO: K103174(TRADITIONAL)
ATTN: ALAN CHANG PHONE NO : 886 222 683100
NO. 9, MINSHENG STREET SE DECISION MADE: 06-MAY-11
TUCHENG CITY, TAIPEI COUNTY TW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URIC ACID MODEL 3P39
ABBOT LABORATORIES 510(k) NO: K102568(TRADITIONAL)
ATTN: LINDA K MORRIS PHONE NO : 972 518 6711
1921 HURD DRIVE SE DECISION MADE: 06-MAY-11
IRVING TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUNITY
CLIENT OUTLOOK INC 510(k) NO: K111164(TRADITIONAL)
ATTN: CHRISTIE EBY PHONE NO : 519 342 6864
295 HAGEY BLVD SE DECISION MADE: 06-MAY-11
WATERLOO CA N2L 6R5 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: INDISTRIP GREEN
INDILAB, INC. 510(k) NO: K110369(TRADITIONAL)
ATTN: MARK ESPENSCHEID PHONE NO : 847 928 1050
10367 FRANKLIN AVE. SE DECISION MADE: 06-MAY-11
FRANKLIN PARK IL 60131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIRA PERITONEAL DRAINAGE SYSTEM
C.R. BARD, INC. 510(k) NO: K110396(SPECIAL)
ATTN: HENRY BOLAND PHONE NO : 801 595 0700
605 NORTH 5600 WEST SE DECISION MADE: 06-MAY-11
SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING
CARDINAL HEALTH, INC. 510(k) NO: K111015(TRADITIONAL)
ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325
1430 WAUKEGAN ROAD SE DECISION MADE: 06-MAY-11
MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
DIAMOND DIAGNOSTICS, INC 510(k) NO: K103364(TRADITIONAL)
ATTN: LIANN VOO PHONE NO : 508 429 0450
333 Fiske St SE DECISION MADE: 06-MAY-11
Holliston MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVA WHEELCHAIR
COLUMBIA MEDICAL MANUFACTURING, LL510(k) NO: K110788(ABBREVIATED)
ATTN: SUSAN JOHNSON PHONE NO : 562 282 0244
11724 WILLAKE STREET SE DECISION MADE: 06-MAY-11
SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMOND-FLEX(R) GRASPERS
CAREFUSION 2200, INC. 510(k) NO: K110257(TRADITIONAL)
ATTN: JANE WEBER PHONE NO : 847 473 7429
1500 WAUKEGAN ROAD SE DECISION MADE: 06-MAY-11
MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOGEN
ORTHOGEN, LLC 510(k) NO: K102208(TRADITIONAL)
ATTN: HAROLD ALEXANDER PHONE NO : 973 467 2404
505 MORRIS AVENUE, SUITE 104 SE DECISION MADE: 06-MAY-11
SPRINGFIELD NJ 07081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOTUS BLAKE ESTEEM SCOOTER
LETRIX POWER HANGZHOU PTY LTD 510(k) NO: K103771(TRADITIONAL)
ATTN: ROBERT DUNN PHONE NO : 714 501 0080
10352 STANFORD RD SE DECISION MADE: 06-MAY-11
GARDEN GROVE CA 92840 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORCETRIAD
COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K102913(SPECIAL)
ATTN: BEN CORDILEONE PHONE NO : 303 530 2300
5920 LONGBOW DRIVE SE DECISION MADE: 06-MAY-11
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX METHAMPHETAMINE ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K092266(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 09-MAY-11
CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103611(TRADITIONAL)
ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494
5976 HEISELY RD. SE DECISION MADE: 09-MAY-11
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN BACTISEAL ENDOSCOPIC VENTICULAR; CODMAN BACTISEAL ENDOSCOPIC VENTRICULAR
CODMAN & SHURTLEFF, INC. 510(k) NO: K110751(TRADITIONAL)
ATTN: SHARON MCDERMOTT PHONE NO : 508 880 8349
325 PARAMOUNT DR. SE DECISION MADE: 09-MAY-11
RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIOPSYS NOVA VEP VISION TESTING SYSTEM
DIOPSYS INC. 510(k) NO: K101763(TRADITIONAL)
ATTN: RICHARD HETTENBACH PHONE NO : 973 214 7468
44 COUNTRYWOOD DRIVE SE DECISION MADE: 09-MAY-11
PINE BROOK NJ 07058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
MAQUET CRITICAL CARE AB 510(k) NO: K102182(ABBREVIATED)
ATTN: WHITNEY TORNING PHONE NO : 973 709 7994
45 BORBOUR POND DRIVE SE DECISION MADE: 09-MAY-11
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELOX RAPID GAUZE
MEDTECH PRODUCTS LTD. 510(k) NO: K110386(TRADITIONAL)
ATTN: JONATHAN RANFIELD PHONE NO : 441 270 500019
ELECTRA HOUSE, CREWE BUSINESS PARKSE DECISION MADE: 10-MAY-11
CHESHIRE UK CW1 6GL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEARL DIABETES MANAGEMENT SYSTEM
M2 GROUP HOLDINGS, INC. 510(k) NO: K100567(TRADITIONAL)
ATTN: NAGHMEH NOURI PHONE NO : 408 716 5652
1012 STEWART DRIVE SE DECISION MADE: 10-MAY-11
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Y BRAND LONG LASTING VAGINAL MOISTURIZER
JOHNSON & JOHNSON CONSUMER & PERSO510(k) NO: K101585(TRADITIONAL)
ATTN: BRAD LAMOTTE,PHARM.D. PHONE NO : 973 385 3667
185 TABOR ROAD SE DECISION MADE: 10-MAY-11
MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNACOR LUBRICATION GEL
MEDLINE INDUSTRIES, INC. 510(k) NO: K103718(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785
ONE MEDLINE PLACE SE DECISION MADE: 10-MAY-11
MUNDELEIN IL 60060 510(k) STATEMENT
DEVICE: CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M
BRIDGE MEDICAL, INC. 510(k) NO: K102725(TRADITIONAL)
ATTN: JILL MUNSINGER PHONE NO : 763 225 8500
2800 CAMPUS DR SUITE 50 SE DECISION MADE: 10-MAY-11
PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEXLER ENDOSCOPE ACCESSORIES
MICROSURGICAL LABORATORIES,INC.DBA510(k) NO: K110121(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713 664 6775
540 COLLEGE STREET SE DECISION MADE: 10-MAY-11
BELLAIRE TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER BIOFIBER SCAFFOLD
TORNIER, INC. 510(k) NO: K102788(TRADITIONAL)
ATTN: LAEL J PICKETT PHONE NO : 952 426 7641
100 CUMMINGS CENTER SUITE 444C SE DECISION MADE: 10-MAY-11
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILIS NXT STEERABLE INTRODUCER
ST. JUDE MEDICAL 510(k) NO: K110450(TRADITIONAL)
ATTN: WENDY PINOR PHONE NO : 651 756 5223
14901 DEVEAU PLACE SE DECISION MADE: 10-MAY-11
MINNETONKA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAHA 3 POWER SOUND PROCESSOR
COCHLEAR AMERICAS 510(k) NO: K110996(SPECIAL)
ATTN: SEAN BUNDY PHONE NO : 800 523 5798
13059 E. PEAKVIEW AVE SE DECISION MADE: 10-MAY-11
CENTENNIAL CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLADIATOR PLASMA CLASSIC HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K110399(TRADITIONAL)
ATTN: MATT PAUL PHONE NO : 901 867 4350
5677 AIRLINE RD. SE DECISION MADE: 10-MAY-11
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
TRUE GLOVE FACTORY 510(k) NO: K110314(TRADITIONAL)
ATTN: FRANK YANG PHONE NO : 865 363 775588
NO.6-1 XINGAN ROAD EAST, LINQU SE DECISION MADE: 10-MAY-11
WEIFANG, SHANDONG CH 262600 510(k) STATEMENT
DEVICE: ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
ALCON RESEARCH, LTD. 510(k) NO: K102860(TRADITIONAL)
ATTN: BETH L SCHULTZ PHONE NO : 817 568 6143
6201 SOUTH FREEWAY SE DECISION MADE: 10-MAY-11
FORT WORTH TX 76134 2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K100910(TRADITIONAL)
ATTN: DONNA VELASQUEZ PHONE NO : 310 645 8200
5210 PACIFIC CONCOURSE DR. SE DECISION MADE: 11-MAY-11
LOS ANGELES CA 90045 6900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
INTERNATIONAL BIOMEDICAL, LTD. 510(k) NO: K103523(SPECIAL)
ATTN: AMY PIEPER PHONE NO : 512 873 0033
8508 CROSS PARK DR. SE DECISION MADE: 11-MAY-11
AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
INTERNATIONAL BIOMEDICAL, LTD. 510(k) NO: K103525(SPECIAL)
ATTN: AMY PIEPER PHONE NO : 512 873 0033
8508 CROSS PARK DR. SE DECISION MADE: 11-MAY-11
AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACHILLES
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K103633(TRADITIONAL)
ATTN: CHRIS PAULIK PHONE NO : 262 548 2010
NO. 19 CHANGJIANG ROAD NATIONAL HISE DECISION MADE: 11-MAY-11
WUXI, JIANGSU PROVINCE CH 21402510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA LED SURGICAL HEADLIGHT SYSTEM
INTEGRA LIFE SCIENCES CORPORATION 510(k) NO: K110528(TRADITIONAL)
ATTN: STEPHANIE SHEESLEY PHONE NO : 717 840 2774
589 DAVIES DRIVE SE DECISION MADE: 11-MAY-11
YORK PA 17402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K110965(TRADITIONAL)
ATTN: DAVID J COLLETTE, MD PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 11-MAY-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIRA PLEURAL DRAINAGE SYSTEM
C.R. BARD, INC. 510(k) NO: K110409(SPECIAL)
ATTN: HENRY BOLAND PHONE NO : 801 595 0700
605 NORTH 5600 WEST SE DECISION MADE: 11-MAY-11
SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
BECKMAN COULTER, INC. 510(k) NO: K110413(SPECIAL)
ATTN: MARINE BOYAJIAN PHONE NO : 714 961 6536
250 SOUTH KRAEMER BLVD SE DECISION MADE: 11-MAY-11
BREA CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOLPHIN IMAGING
PATTERSON DENTAL SUPPLY, INC. 510(k) NO: K110430(TRADITIONAL)
ATTN: DAWN LI PHONE NO : 651 905 3203
1031 MENDOTA HEIGHTS RD. SE DECISION MADE: 11-MAY-11
ST. PAUL MN 55120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURADORM (NEUROMUSCULAR SLEEP)
SLEEPWRIGHT 510(k) NO: K101155(TRADITIONAL)
ATTN: CYNTHIA WRIGHT PHONE NO : 505 989 7866
27 TIMBERWICK RD SE DECISION MADE: 12-MAY-11
SANTA FE NM 87508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
ROCHE DIAGNOSTICS 510(k) NO: K103716(SPECIAL)
ATTN: KATHIE J GOODWIN PHONE NO : 317 521 3831
9115 HAGUE ROAD SE DECISION MADE: 12-MAY-11
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUSTANG BALLOON DILATAION CATHETERS
BOSTON SCIENTIFIC 510(k) NO: K110122(TRADITIONAL)
ATTN: ANNE V ROSSI PHONE NO : 763 255 0681
ONE SCIMED PLACE SE DECISION MADE: 12-MAY-11
MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STREAMLINE TL SPINAL SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K110692(SPECIAL)
ATTN: EMILY M DOWNS PHONE NO : 906 225 5602
375 RIVER PARK CIRCLE SE DECISION MADE: 12-MAY-11
MARQUETTE MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLEABI
NEWMAN MEDICAL 510(k) NO: K110628(TRADITIONAL)
ATTN: SPENCER NEWMAN PHONE NO : 847 283 9177
42 SHERWOOD TERRACE SUITE 2 SE DECISION MADE: 12-MAY-11
LAKE BLUFF IL 60044 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: DROPPER A1C DIABETES CONTROL
QUANTIMETRIX CORP. 510(k) NO: K103744(TRADITIONAL)
ATTN: KALYNA SNYLYK PHONE NO : 310 536 0006
2005 MANHATTAN BEACH BLVD. SE DECISION MADE: 12-MAY-11
REDONDO BEACH CA 90278 1205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVEA VENTILATOR
CAREFUSION 510(k) NO: K103211(TRADITIONAL)
ATTN: FAROKH ETEMADIEH PHONE NO : 714 922 7615
22745 SAVI RANCH PARKWAY SE DECISION MADE: 12-MAY-11
YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPD-Y0003
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K103312(TRADITIONAL)
ATTN: STACY KLUESNER PHONE NO : 484 896 5405
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 12-MAY-11
CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEASPINE SPACER SYSTEM
SEASPINE, INC. 510(k) NO: K102026(TRADITIONAL)
ATTN: DAN MILLER PHONE NO : 760 727 8399
2301 LA MIRADA DR SE DECISION MADE: 12-MAY-11
VISTA CA 92081 510(k) STATEMENT
DEVICE: ACTIVECARE SFT
MEDICAL COMPRESSION SYSTEMS (DBN) 510(k) NO: K110159(TRADITIONAL)
ATTN: ORLY MAOR PHONE NO : 972 974 53607
25 A SIRKIN STREET SE DECISION MADE: 12-MAY-11
KFAR SABA IS 44421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PROLACTIN II CALCHECK 5
ROCHE DIAGNOSTICS 510(k) NO: K110613(TRADITIONAL)
ATTN: KELLY COLLEEN O'MAINE ADAMSPHONE NO : 317 521 3577
9115 HAGUE ROAD SE DECISION MADE: 12-MAY-11
INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARBLUE EASY PREGNANCY TEST
SPD DEVELOPMENT COMPANY LIMITED 510(k) NO: K110433(SPECIAL)
ATTN: TANYA FAIR PHONE NO : 440 123 4835290
STANNARD WAY PRIORY BUSINESS PARK SE DECISION MADE: 12-MAY-11
BEDFORD, BEDFORDSHIRE UK MK44 510(k) STATEMENT
DEVICE: INVADER MTHFR 677
HOLOGIC, INC. 510(k) NO: K100987(TRADITIONAL)
ATTN: RANDALL COVILL PHONE NO : 508 263 8853
250 CAMPUS DRIVE SE DECISION MADE: 13-MAY-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
TANGSHAN KAIYUE GLOVE CO., LTD. 510(k) NO: K110146(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
RM 1606 BLDG 1 JIANXIANG YUAN NO 2SE DECISION MADE: 13-MAY-11
HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COUGAR LS LATERAL CAGE SYSTEM
JOHNSON & JOHNSON 510(k) NO: K110454(SPECIAL)
ATTN: KEVIN G STEVENS PHONE NO : 508 977 6445
325 PARAMOUNT DR. SE DECISION MADE: 13-MAY-11
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL PACIFIER THERMOMETER
ABERTEK 510(k) NO: K103407(TRADITIONAL)
ATTN: TANI MOK PHONE NO : 867 558 1436181
4F, BLOCK 4, FU YUAN IND. ZONE JUISE DECISION MADE: 13-MAY-11
SHENZHEN, GUANG DONG PROVINCE C510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO SUPPORT CATHETER
TERUMO MEDICAL CORP. 510(k) NO: K110540(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410 392 7213
950 ELKTON BLVD. SE DECISION MADE: 13-MAY-11
ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
AEROGEN LTD 510(k) NO: K103635(SPECIAL)
ATTN: MARTHA FOLAN PHONE NO : 353 91 502550
GALWAY BUSINESS PARK, DANGAN SE DECISION MADE: 13-MAY-11
GALWAY EI GALWAY 510(k) STATEMENT
DEVICE: VR MEDICAL ENTERAL ORAL SYRINGE
VR MEDICAL 510(k) NO: K110853(TRADITIONAL)
ATTN: LEE PAN PHONE NO :
90 GAO XIN ROAD SE DECISION MADE: 13-MAY-11
ZHOUZHUANG CH 215325 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ANGIODYNAMICS, INC. VENACURE 1470 LASER
ANGIODYNAMICS, INC. 510(k) NO: K110225(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518 795 1142
14 PLAZA DRIVE SE DECISION MADE: 13-MAY-11
LATHAM NY 12110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAUTIBOND MULTI
SHOFU DENTAL CORP. 510(k) NO: K110235(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277
1225 STONE DR. SE DECISION MADE: 13-MAY-11
SAN MARCOS CA 92078 510(k) STATEMENT
DEVICE: HI-DOW-XP
HI-DOW INTERNATIONAL INC. 510(k) NO: K102598(TRADITIONAL)
ATTN: ERIC CHEN PHONE NO : 314 569 2888
2071 CONGRESSIONAL DR SE DECISION MADE: 13-MAY-11
ST LOUIS MO 63146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
PREVENTIVE CARE, INC. 510(k) NO: K110102(TRADITIONAL)
ATTN: ANIL SEGAT PHONE NO : 651 322 9120
15215 BOULDER TRAIL SE DECISION MADE: 13-MAY-11
ROSEMOUNT MN 55068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAUTIBOND MULTI PR PLUS
SHOFU DENTAL CORP. 510(k) NO: K110252(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277
1225 STONE DR. SE DECISION MADE: 13-MAY-11
SAN MARCOS CA 92078 510(k) STATEMENT
DEVICE: ELECTRONIC SPHYGMOMANOMETER
CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K110774(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 122 815850
P.O. BOX 237-023 SE DECISION MADE: 13-MAY-11
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEISENBERG DYEING LIQUIDS
3M ESPE AG 510(k) NO: K111257(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 498 152 7001169
ESPE PLATZ SE DECISION MADE: 13-MAY-11
SEEFELD GM 82229 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
PROXY BIOMEDICAL LTD. 510(k) NO: K111121(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035
P.O. BOX 560 SE DECISION MADE: 13-MAY-11
STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOBON XENOGRAFT GRANULES
BIOMET 3I 510(k) NO: K110449(TRADITIONAL)
ATTN: MARTHA I GARAY PHONE NO : 561 776 6923
4555 RIVERSIDE DRIVE SE DECISION MADE: 13-MAY-11
PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
SHANDONG WEIGAO GROUP MEDICAL POLY510(k) NO: K102328(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 237-023 SE DECISION MADE: 13-MAY-11
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH CARE SYSTEM SOFTWARE
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K110948(SPECIAL)
ATTN: TELING HSU PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 13-MAY-11
NEW TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K111227(TRADITIONAL)
ATTN: YUKITOSHI KIYOMURA PHONE NO : 81 422 455595
10 FAIRFIELD BLVD. SE DECISION MADE: 13-MAY-11
WALLINGFORD CT 06492 7502 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CLICK-IT
TP ORTHODONTICS, INC. 510(k) NO: K111234(TRADITIONAL)
ATTN: ROBIN INTAGLIATA PHONE NO : 219 785 2591
100 CENTER PLAZA SE DECISION MADE: 13-MAY-11
LA PORTE IN 46350 0073 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BD SINGLE USE, HYPODERMIC SYRINGE
BECTON, DICKINSON AND COMPANY 510(k) NO: K110771(SPECIAL)
ATTN: JOHN ROBERTS PHONE NO : 201 847 5473
1 BECTON DRIVE MC237 SE DECISION MADE: 13-MAY-11
FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRONIC SPHYGMOMANOMETER
CONTEC MEDICAL SYSTEMS CO., LTD. 510(k) NO: K110775(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 237-423 SE DECISION MADE: 13-MAY-11
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO.VIA WEB VIEWER
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K111079(TRADITIONAL)
ATTN: SVEN KNOKE PHONE NO : 49 913 1844687
HENKESTRASSE 127 SE DECISION MADE: 13-MAY-11
ERLANGEN GM D-91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIMENSIONS HB1C KIT, MODEL DF105A
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K102510(TRADITIONAL)
ATTN: ANNA MARIE ENNIS PHONE NO : 302 631 9352
500 GBC DRIVE PO BOX 6101 SE DECISION MADE: 13-MAY-11
NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T
RAPID BIOMEDICAL GMBH 510(k) NO: K102748(ABBREVIATED)
ATTN: ARMIN PUREA PHONE NO : 49 936 588260
KETTELERSTR. 3-11 TECHNOLOGIEPARK SE DECISION MADE: 13-MAY-11
RIMPAR, BAVARIA GM 97222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BT-350
BISTOS CO., LTD. 510(k) NO: K103545(TRADITIONAL)
ATTN: STEVE KOHN PHONE NO : 718 339 6212
4802 GLENWOOD ROAD SE DECISION MADE: 13-MAY-11
BROOKLYN NY 11234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
GIVEN IMAGING LTD. 510(k) NO: K103025(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 770 662 0870
P.O. BOX 258 NEW INDUSTRIAL PARK SE DECISION MADE: 13-MAY-11
YOQNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAHE FIXATION PLATE AND SCREW SYSTEM
MAHE MEDICAL GMBH 510(k) NO: K102845(TRADITIONAL)
ATTN: ANDREA PECSI PHONE NO : 497 462 924051
SCHWARZWALDSTRASSE 5 SE DECISION MADE: 13-MAY-11
TUTTLINGEN, BW GR 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUTED RADDIOGRAPHY SCANNER
3DISC AMERICAS 510(k) NO: K102619(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 13-MAY-11
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
NATUS MEDICAL INCORPORATED 510(k) NO: K103589(TRADITIONAL)
ATTN: JULIE FREED PHONE NO : 800 426 0353
5900 FIRST AVENUE SOUTH SE DECISION MADE: 13-MAY-11
SEATTLE WA 98108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
ZOLL MEDICAL CORPORATION 510(k) NO: K103473(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH PHONE NO : 978 421 9786
269 MILL ROAD SE DECISION MADE: 13-MAY-11
CHELMSFORD MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONESTEP PEDIATRIC MFE'S
ZOLL MEDICAL CORPORATION 510(k) NO: K110978(ABBREVIATED)
ATTN: ROBERT MORSE PHONE NO : 866 639 0060
525 NARRAGANSETT PARK DRIVE SE DECISION MADE: 13-MAY-11
PAWTUCKET RI 02861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATUS CS ACUTE CARE D-DIMER
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K110303(TRADITIONAL)
ATTN: KATHLEEN ANN DRAY-LYONS PHONE NO : 781 826 4551
500 GBC DRIVE PO BOX 6101 SE DECISION MADE: 16-MAY-11
NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFAST CTNL-II TEST, PATHFAST CTNL CALIBRATORS, PATHFAST SAMPLE DILUENT 2
MITSUBISHI CHEMICAL MEDIENCE CO 510(k) NO: K100130(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410 592 2060
PO BOX 103 SE DECISION MADE: 16-MAY-11
BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
SONOSCAPE COMPANY LIMITED 510(k) NO: K110510(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467
P.O. BOX 237-023 SE DECISION MADE: 16-MAY-11
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
JPI HEALTHCARE CO., LTD 510(k) NO: K101779(TRADITIONAL)
ATTN: WILLIAM LITTLE PHONE NO : 516 513 1330
170-5 Guro-3 Dong, #608 KURO-GU SE DECISION MADE: 16-MAY-11
Seoul KS 152-847 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510
PERCUTANEOUS SYSTEMS, INC. 510(k) NO: K102887(TRADITIONAL)
ATTN: THOMAS LAWSON, PHD PHONE NO : 650 493 4200
3260 HILLVIEW AVE. SE DECISION MADE: 16-MAY-11
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNATURE PLANNER / SIGNATURE GUIDES
MATERIALISE N.V. 510(k) NO: K110415(TRADITIONAL)
ATTN: ALEXANDRA RAZZHIVANA PHONE NO : 321 639 6280
15 TECHNOLOGIELAAN SE DECISION MADE: 16-MAY-11
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
OPTOMED OY 510(k) NO: K110986(TRADITIONAL)
ATTN: LAURA PIILA PHONE NO : 358 207 413380
HALLITUSKATU 13-17 D 96 SE DECISION MADE: 16-MAY-11
OULU FI 90100 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FUJINON ULTRASONIC PROCESSOR
FUJINON INC. 510(k) NO: K111243(SPECIAL)
ATTN: KATHERINE Y CHOI PHONE NO : 203 602 3568
419 WEST AVENUE SE DECISION MADE: 16-MAY-11
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
BIOMERIEUX SA 510(k) NO: K102535(TRADITIONAL)
ATTN: ASA KARLSSON PHONE NO : 330 478 875389
5 RUE DES AQUEDUCS SE DECISION MADE: 16-MAY-11
CRAPONNE FR 69290 510(k) STATEMENT
DEVICE: CHITOGAUZE FUSION
HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K111163(SPECIAL)
ATTN: KENDRA RATHKEY PHONE NO : 503 245 0459
10575 SW CASCADE AVENUE SUITE 130 SE DECISION MADE: 17-MAY-11
PORTLAND OR 97223 4363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
EXACTECH, INC. 510(k) NO: K110706(TRADITIONAL)
ATTN: GRAHAM L CUTHBERT PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 17-MAY-11
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K103094(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 756 4386
ONE EDWARDS WAY SE DECISION MADE: 17-MAY-11
IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
NOVOCOL, INC. 510(k) NO: K110484(TRADITIONAL)
ATTN: CORA BRACHO-TROCONIS PHONE NO : 303 665 7535
416 SOUTH TAYLOR AVE. SE DECISION MADE: 17-MAY-11
LOUISVILLE CO 80027 510(k) STATEMENT
DEVICE: MAC 600 RESTING ECG ANALYSIS SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K103765(TRADITIONAL)
ATTN: JOE LUCAS PHONE NO : 414 721 2594
9900 INOVATION DRIVE SE DECISION MADE: 17-MAY-11
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RPS ADENO DETECTOR PLUS
RAPID PATHOGEN SCREENING, INC. 510(k) NO: K110722(TRADITIONAL)
ATTN: DOUGLAS BUESCHEL PHONE NO : 941 556 1850
7227 DELAINEY COURT SE DECISION MADE: 17-MAY-11
SARASOTA FL 34240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
DIAZYME LABORATORIES 510(k) NO: K110188(SPECIAL)
ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762
12889 GREGG COURT SE DECISION MADE: 17-MAY-11
POWAY CA 92064 510(k) STATEMENT
DEVICE: COLONCAD API 3.1
MEDICSIGHT PLC 510(k) NO: K083423(TRADITIONAL)
ATTN: AMARJIT GILL PHONE NO : 440 207 6057954
66 HAMMERSMITH ROAD SE DECISION MADE: 17-MAY-11
LONDON UK W148UD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE STORM (R) OPERATING KIT
INTELLIGENT ORTHOPAEDICS LTD 510(k) NO: K111001(SPECIAL)
ATTN: PETER J OGRODNIK PHONE NO : 448 448 004405
STAFFORDSHIRE UNIVERSITY BUSINESS SE DECISION MADE: 17-MAY-11
STOKE ON TRENT, STAFFORDSHIRE U510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMOTE VIEW SOFTWARE
CARIESCAN LTD. 510(k) NO: K111321(SPECIAL)
ATTN: NIKOLA SKELLY PHONE NO : 440 138 2560910
UNIT 5 GATEWAY WEST, LUNA PLACE, TSE DECISION MADE: 17-MAY-11
DUNDEE, ANGUS UK DD2 1XZ 510(k) STATEMENT
DEVICE: DASH KNEE
BRAINLAB AG 510(k) NO: K102251(SPECIAL)
ATTN: ALEXANDER SCHWIERSCH PHONE NO : 498 999 15680
KAPELLENSTRASSE 12 SE DECISION MADE: 17-MAY-11
FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQ VENTILATION NASAL MASK
SLEEPNET CORPORATION 510(k) NO: K102317(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 17-MAY-11
BONITA SPRINGS FL 34134 2958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
BRIVANT, LTD. 510(k) NO: K103377(SPECIAL)
ATTN: TOMAS FUREY PHONE NO : 353 913 85037
PARKMORE WEST BUSINESS PARK SE DECISION MADE: 18-MAY-11
GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
VISION-SCIENCES, INC. 510(k) NO: K102733(TRADITIONAL)
ATTN: LILLIAN QUINTERO PHONE NO : 845 365 0600
40 RAMLAND RD. SOUTH SE DECISION MADE: 18-MAY-11
ORANGEBURG NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROG SUTURE ANCHOR 5.5MM, 2.9MM
ROG SPORTS MEDICINE, INC. 510(k) NO: K110229(TRADITIONAL)
ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105
80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 18-MAY-11
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
BIOMET MICROFIXATION, INC. 510(k) NO: K110574(SPECIAL)
ATTN: SHERYL MALMBERG PHONE NO : 904 741 9465
1520 TRADEPORT DR. SE DECISION MADE: 18-MAY-11
JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIS SYMPHONY IMAGE MANAGMENT SYSTEM
OPHTHALMIC IMAGING SYSTEMS 510(k) NO: K110006(TRADITIONAL)
ATTN: ANDREA AMBROSE PHONE NO : 916 646 2020
221 LATHROP WAY, SUITE I SE DECISION MADE: 18-MAY-11
SACRAMENTO CA 95815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHASER IPL HAIR REMOVAL SYSTEM
SHASER, INC. 510(k) NO: K103560(TRADITIONAL)
ATTN: GLEN EMELOCK PHONE NO : 781 665 9893
32 HARRISON ST. SE DECISION MADE: 18-MAY-11
MELROSE MA 02176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS TOXO IGG AVIDITY
BIOMERIEUX, INC. 510(k) NO: K101946(TRADITIONAL)
ATTN: MARLENE CHAVAROCHE PHONE NO : 314 731 8385
595 ANGLUM RD. SE DECISION MADE: 18-MAY-11
HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGERPAW SYSTEM II
LAAX, INC. 510(k) NO: K111064(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 925 254 5228
8 SNOWBERRY COURT SE DECISION MADE: 18-MAY-11
ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MITRA-LIFT
SCIENCITY CO., LTD 510(k) NO: K103812(TRADITIONAL)
ATTN: JOYCE BANG PHONE NO : 714 525 0114
325 N. PUENTE ST. UNIT B SE DECISION MADE: 18-MAY-11
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES HEMOSTATIC BONE PUTTY (HBP)
SYNTHES USA PRODUCTS, LLC 510(k) NO: K103822(TRADITIONAL)
ATTN: JEFFREY L DOW PHONE NO : 484 356 9720
1230 WILSON BLVD. SE DECISION MADE: 19-MAY-11
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
SEPPIM S.A.S. 510(k) NO: K100547(TRADITIONAL)
ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174
21720 23RD DR SE SUITE 150 SE DECISION MADE: 19-MAY-11
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARK CARE DIABETES MANAGMENT SYSTEM
ARKRAY FACTORY USA, INC. 510(k) NO: K110709(TRADITIONAL)
ATTN: TYLER FOUTCH PHONE NO : 952 646 3171
5182 WEST 76TH ST. SE DECISION MADE: 19-MAY-11
MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PATIENT SPECIFIC CUTTING GUIDE
STRYKER CORP. 510(k) NO: K110533(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201 831 5718
325 CORPORATE DRIVE SE DECISION MADE: 19-MAY-11
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROG KNOTLESS SUTURE ANCHOR
ROG SPORTS MEDICINE, INC. 510(k) NO: K110230(TRADITIONAL)
ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105
80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 19-MAY-11
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZENIUS SPINAL SYSTEM
MEDYSSEY CO., LTD. 510(k) NO: K110283(SPECIAL)
ATTN: PATRICK MOORE PHONE NO : 801 266 4811
6170 SOUTH 380 WEST SUITE 200 SE DECISION MADE: 19-MAY-11
MURRAY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
SEPPIM S.A.S. 510(k) NO: K102993(TRADITIONAL)
ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174
21720 23RD DR SE SUITE 150 SE DECISION MADE: 19-MAY-11
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
ZIMMER, INC. 510(k) NO: K111039(SPECIAL)
ATTN: STEPHEN H MCKELVEY PHONE NO : 574 372 4944
P.O. BOX 708 SE DECISION MADE: 19-MAY-11
WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADHESIVE EXL-759
3M ESPE AG 510(k) NO: K110302(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 498 152 7001169
ESPE PLATZ SE DECISION MADE: 19-MAY-11
SEEFELD, BAVARIA GM D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERAMIC BRACKETS
ORTHO ORGANIZERS, INC. 510(k) NO: K110335(TRADITIONAL)
ATTN: FOSTER BOOP PHONE NO : 760 448 8600
1822 ASTON AVENUE SE DECISION MADE: 19-MAY-11
CARLSBAD CA 92008 7603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIMAX SUCTION IRRIGATION SET
UNIMAX MEDICAL SYSTEMS, INC. 510(k) NO: K103509(TRADITIONAL)
ATTN: MICHAEL LEE PHONE NO : 886 228 096995
NO. 45, MINSHEN RD. DANSHUI TOWN SE DECISION MADE: 19-MAY-11
TAIPEI COUNTY TW 251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOENIX HEMODIALYSIS DELIVERY SYSTEM
GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K103832(TRADITIONAL)
ATTN: KAE MILLER PHONE NO : 303 222 6724
14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 20-MAY-11
LAKEWOOD CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
MEDICA CORP. 510(k) NO: K101090(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892
5 OAK PARK DRIVE SE DECISION MADE: 20-MAY-11
BEDFORD MA 01730 510(k) STATEMENT
DEVICE: CLEARCUT S SAFETY KNIFE
ALCON RESEARCH, LTD. 510(k) NO: K110166(ABBREVIATED)
ATTN: TONYA MORGAN PHONE NO : 817 551 8723
6201 SOUTH FREEWAY SE DECISION MADE: 20-MAY-11
FORT WORTH TX 76134 2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SICAT IMPLANT V1.2
SICAT GMBH & CO. KG 510(k) NO: K103723(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 508 316 7151
49 PLAIN STREET SE DECISION MADE: 20-MAY-11
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFTKAR PT
SANO TRANSPORTGERATE GMBH 510(k) NO: K110495(TRADITIONAL)
ATTN: JEANINE A CARROCCIO PHONE NO : 630 891 2817
4028 BELLEAIRE LANE SE DECISION MADE: 20-MAY-11
DOWNERS GROVE IL 60515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K103603(TRADITIONAL)
ATTN: EWA NADOLCZAK PHONE NO : 908 526 3744
200 EVANS WAY SE DECISION MADE: 20-MAY-11
BRANCHBURG NJ 08876 510(k) STATEMENT
DEVICE: WITHINGS BLOOD PRESSURE MONITOR
WITHINGS 510(k) NO: K110872(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO.58, FU CHIUN STREET SE DECISION MADE: 20-MAY-11
HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO NEURO PBV-IR
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K111052(SPECIAL)
ATTN: GARY L JOHNSON PHONE NO : 610 448 1778
51 VALLEY STREAM PKWY. MAIL CODE GSE DECISION MADE: 20-MAY-11
MALVERN PA 19355 1406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABS BLOWER, ABS NOZZLE, MODEL 1001
NIMBIC SYSTEMS, LLC 510(k) NO: K092801(TRADITIONAL)
ATTN: SEAN SELF PHONE NO : 281 565 5700
4910 WRIGHT ROAD, SUITE 170 SE DECISION MADE: 20-MAY-11
STAFFORD TX 77477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESIGNS VSI VITAL SIGNS MONITOR
PHILIPS MEDICAL SYSTEMS 510(k) NO: K110803(TRADITIONAL)
ATTN: MARY KRUITWAGEN PHONE NO : 978 659 4932
3000 MINUTEMAN RD. SE DECISION MADE: 20-MAY-11
ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESIGNS VS2 VITAL SIGNS MONITOR
PHILIPS MEDICAL SYSTEMS 510(k) NO: K111114(SPECIAL)
ATTN: KRISTEN LESSARD PHONE NO : 978 659 4219
3000 MINUTEMAN ROAD SE DECISION MADE: 20-MAY-11
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNABINOIDS URINE TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K110182(TRADITIONAL)
ATTN: JOE SHIA PHONE NO : 240 505 7880
504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 20-MAY-11
GAITHERSBURG MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALSENS, AINGEAL, V-POD
INTELESENS LIMITED 510(k) NO: K110015(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 20-MAY-11
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERCONTINENTAL PLATE-SPACER
GLOBUS MEDICAL INC. 510(k) NO: K103382(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 20-MAY-11
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
MAR COR PURIFICATION, INC. 510(k) NO: K110578(TRADITIONAL)
ATTN: BRENT GEIGER PHONE NO : 763 553 3345
14605 28TH AVENUE NORTH SE DECISION MADE: 20-MAY-11
MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K2M COCR WIRE
K2M, INC. 510(k) NO: K103797(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR.,SE SE DECISION MADE: 20-MAY-11
LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORELEADER COLLA-PAD MODEL CS 03030
CORELEADER BIOTECH CO., LTD. 510(k) NO: K102946(TRADITIONAL)
ATTN: IAN LI PHONE NO : 886 226 968880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 20-MAY-11
TAIPEI, TAIWAN TW 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JBAIDS Q FEVER DETECTION KIT
IDAHO TECHNOLOGY, INC. 510(k) NO: K103207(TRADITIONAL)
ATTN: BETH LINGENFELTER PHONE NO : 801 736 6354
390 WAKARA WAY SE DECISION MADE: 20-MAY-11
SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXSALT SD7 WOUND DRESSING
EXCITON TECHNOLOGIES INC. 510(k) NO: K103067(TRADITIONAL)
ATTN: ROD PRECHT PHONE NO : 780 248 5868
SUITE 4232, 10230 JASPER AVE SE DECISION MADE: 20-MAY-11
EDMONTON CA T5J 4P6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPOTHERMX INTRAVENOUS FLUID WARMER
EMIT CORPORATION 510(k) NO: K103801(TRADITIONAL)
ATTN: DARLA J ELKIN PHONE NO : 281 450 8163
42 NORTH CHATSONG CIRCLE SE DECISION MADE: 20-MAY-11
WOODLANDS TX 77382 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6
BIOMERIEUX, INC. 510(k) NO: K102740(TRADITIONAL)
ATTN: JOCELYN JENNINGS PHONE NO : 919 620 2894
100 RODOLPHE ST SE DECISION MADE: 20-MAY-11
DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RMS SUBCUTANEOUS NEEDLE SET
REPRO-MED SYSTEMS, INC. 510(k) NO: K102512(TRADITIONAL)
ATTN: ANDREW SEALFON PHONE NO : 845 469 2042
24 CARPENTER RD. SE DECISION MADE: 20-MAY-11
CHESTER NY 10918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
GYRUS ACMI, INC. 510(k) NO: K102970(TRADITIONAL)
ATTN: LORRAINE CALZETTA PHONE NO : 508 804 2752
136 TURNPIKE RD. SE DECISION MADE: 20-MAY-11
SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROFIX VASO SHIELD
MIMEDX GROUP INC 510(k) NO: K111137(SPECIAL)
ATTN: SALLY THORSEN PHONE NO : 678 384 6720
811 LIVINGSTON COURT SE SE DECISION MADE: 20-MAY-11
MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
EPS BIO TECHNOLOGY CORP. 510(k) NO: K101037(TRADITIONAL)
ATTN: YC LEI PHONE NO : 886 366 86868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 23-MAY-11
HSINCHU CITY TW 30077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE EMBOLIC FILTER
W.L. GORE & ASSOCIATES,INC 510(k) NO: K103500(TRADITIONAL)
ATTN: MICHELLE A WELLS PHONE NO : 800 437 8181
4250 WEST KILTIE LANE SE DECISION MADE: 23-MAY-11
FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K110676(SPECIAL)
ATTN: KEVIN FORD PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 23-MAY-11
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GELPOINT PATH
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K110792(TRADITIONAL)
ATTN: FRANS VANDENBROEK PHONE NO : 949 713 8369
22872 AVENIDA EMPRESA SE DECISION MADE: 23-MAY-11
RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
BIOTRONIK, INC. 510(k) NO: K111154(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374
6024 JEAN ROAD SE DECISION MADE: 23-MAY-11
LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
TANGSHAN XIANGRUI PLASTIC PRODUCTS510(k) NO: K110155(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG.1JIANXIANG YUAN NO.SE DECISION MADE: 23-MAY-11
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
SOPHONO, INC 510(k) NO: K102199(TRADITIONAL)
ATTN: CLAY ANSELMO PHONE NO : 303 832 8200
555 ZANG STREET SUITE 100 SE DECISION MADE: 23-MAY-11
LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLIT LAMP SL-2G
TOPCON MEDICAL SYSTEMS, INC. 510(k) NO: K110489(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245
5 TIMBER LANE SE DECISION MADE: 23-MAY-11
NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE
AZE, LTD. 510(k) NO: K102534(TRADITIONAL)
ATTN: ANDY ANDERSON PHONE NO : 952 746 8079
5353 WAYZATA BLVD. SUITE 505 SE DECISION MADE: 24-MAY-11
MINNEAPOLIS MN 55416 1334 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
SYNTHES (USA) PRODUCTS LLC 510(k) NO: K111230(TRADITIONAL)
ATTN: REBECCA BLANK PHONE NO : 610 719 1268
1301 GOSHEN PKWY. SE DECISION MADE: 24-MAY-11
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
C.R. BARD, INC. 510(k) NO: K111153(SPECIAL)
ATTN: ZHENG LIU PHONE NO : 401 825 8671
100 CROSSINGS BOULEVARD SE DECISION MADE: 24-MAY-11
WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4D LV-ANALYSIS 3.0
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K110746(TRADITIONAL)
ATTN: INGE SCHEIDT PHONE NO : 498 932 175515
EDISONSTRASSE 6 SE DECISION MADE: 24-MAY-11
UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL SHOULDER SYSTEM
SHOULDER INNOVATIONS, LLC 510(k) NO: K110905(SPECIAL)
ATTN: ANDREW RODENHOUSE PHONE NO : 616 706 3903
4670 FULTON STREET EAST SE DECISION MADE: 24-MAY-11
ADA MI 49301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET SOLENT OMNI THROMBECTOMY SET
MEDRAD, INC. 510(k) NO: K111182(SPECIAL)
ATTN: DOUG ATKINS PHONE NO : 763 780 4555
9055 EVERGREEN BLVD NW SE DECISION MADE: 24-MAY-11
MINNEAPOLIS MN 55433 8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
ORTHOFIX INC. 510(k) NO: K111183(SPECIAL)
ATTN: DARLA CHEW PHONE NO : 214 937 2000
3451 PLANO PARKWAY SE DECISION MADE: 24-MAY-11
LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARSTASIS DILATOR ADAPTER
ARSTASIS, INC. 510(k) NO: K103421(TRADITIONAL)
ATTN: DEBRA COGAN PHONE NO : 650 508 1549
1021 HOWARD AVE SUITE C SE DECISION MADE: 24-MAY-11
SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEBRIDGE
LIFEBRIDGE MEDIZINTECHNIK AG 510(k) NO: K111384(SPECIAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 641 472 0775
P.O. BOX 2042 SE DECISION MADE: 24-MAY-11
FAIRFIELD IA 52556 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBW NM 2.0
PHILIPS MEDICAL SYSTEMS (CLEVELAN510(k) NO: K111336(TRADITIONAL)
ATTN: LORI R PETERSON PHONE NO : 408 468 3042
3860 N. First Street SE DECISION MADE: 24-MAY-11
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SMART LEISH, MODEL LGM1-050
U.S. ARMY MEDICAL RESEARCH INSTITU510(k) NO: K081868(TRADITIONAL)
ATTN: ROBER MILLER PHONE NO : 301 619 0317
1452 PORTER STREET SE DECISION MADE: 25-MAY-11
FORT DETRICK MD 21702 9232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX BARITURATES ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K092268(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 25-MAY-11
CRUMLIN, COUNTY ANTRIM UK BT29 510(k) STATEMENT
DEVICE: SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
SURGIQUEST, INC. 510(k) NO: K103692(TRADITIONAL)
ATTN: DANIEL DONOVAN PHONE NO : 203 799 2400
12 CASCADE BLVD. SUITE 2B SE DECISION MADE: 25-MAY-11
ORANGE CT 06477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABG II MONOLITHIC HIP STEM
STRYKER CORP. 510(k) NO: K110807(TRADITIONAL)
ATTN: STEPHANIE FITTS PHONE NO : 201 831 5405
325 CORPORATE DRIVE SE DECISION MADE: 25-MAY-11
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLASSIX CHEMICAL STERILIZATION INDICATOR
PROPPER MFG. CO., INC. 510(k) NO: K102894(ABBREVIATED)
ATTN: ANDREW SHARAVARA PHONE NO : 800 832 4300
36-04 SKILLMAN AVE. SE DECISION MADE: 25-MAY-11
LONG ISLAND CITY NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON MULTI CALIBRATOR
BECKMAN COULTER, INC. 510(k) NO: K110251(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 714 961 3626
250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 25-MAY-11
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEUCADIA PEDICLE SCREW SYSTEM
PHYGEN, LLC 510(k) NO: K110588(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 949 752 7885
2301 DUPONT DRIVE SUITE 510 SE DECISION MADE: 25-MAY-11
IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUSE CARDIOLOGY INFORMATION SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K110132(TRADITIONAL)
ATTN: KRISTIN PABST PHONE NO : 414 721 3104
9900 WEST INNOVATION DRIVE SE DECISION MADE: 25-MAY-11
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGER SPINE SYSTEM
CORELINK, LLC 510(k) NO: K110321(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199
101 OAKWOOD BLVD SE DECISION MADE: 25-MAY-11
ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON DIGITAL VIDEO PROCESSOR
FUJINON, INC. 510(k) NO: K102466(TRADITIONAL)
ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105
80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 25-MAY-11
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-V COAT
BISCO, INC. 510(k) NO: K103514(TRADITIONAL)
ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 25-MAY-11
SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOTACK SUTURE ANCHOR 1.4MM
PIVOT MEDICAL 510(k) NO: K110473(TRADITIONAL)
ATTN: JON COOK PHONE NO : 408 774 1452
247 HUMBOLDT CT. SE DECISION MADE: 25-MAY-11
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL STIMULATORS
TECHNOMED EUROPE 510(k) NO: K110422(TRADITIONAL)
ATTN: PIERRE VREULS PHONE NO : 310 434 086868
AMERIKALAAN 71 SE DECISION MADE: 26-MAY-11
MAASTRICHT AIRPORT NL 6199 AE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-CHEX WITH CPPD CRYSTALS
STRECK 510(k) NO: K110718(TRADITIONAL)
ATTN: DEBORAH KIPP PHONE NO : 402 537 5215
7002 SOUTH 109TH ST. SE DECISION MADE: 26-MAY-11
OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFX INTRODUCER SYSTEM
ENDOLOGIX, INC. 510(k) NO: K110090(TRADITIONAL)
ATTN: JANET M FAULS PHONE NO : 949 595 7203
11 STUDEBAKER SE DECISION MADE: 26-MAY-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE CRYO MODULE
ATRICURE, INC. 510(k) NO: K111042(TRADITIONAL)
ATTN: REBECCA WALTERS PHONE NO : 513 755 4576
6217 CENTRE PARK DRIVE SE DECISION MADE: 26-MAY-11
WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: E3 TORQUE CONTROL MOTOR
DENTSPLY INTERNATIONAL INC. 510(k) NO: K103653(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717 845 7511
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 26-MAY-11
YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
FILLIGENT LIMITED 510(k) NO: K101128(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 512 327 9997
611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 26-MAY-11
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYFRA 21-1 EIA MODEL 211-10
FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K100831(TRADITIONAL)
ATTN: STACEY DOLAN PHONE NO : 610 240 3843
201 GREAT VALLEY PARKWAY SE DECISION MADE: 26-MAY-11
MALVERN PA 19355 1307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDAX UNIPERSONALE SRL
MEDAX UNIPERSONALE SRL 510(k) NO: K092338(TRADITIONAL)
ATTN: FLAVIO TOMASSINI PHONE NO : 305 594 8565
3016 N.W. 82ND AVE. SE DECISION MADE: 27-MAY-11
MIAMI FL 33122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K101681(ABBREVIATED)
ATTN: LEO WANG PHONE NO : 086 288 6083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 27-MAY-11
CHENGDU, SICHUAN CH 610041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
DIPPED PRODUCTS LIMITED 510(k) NO: K100895(TRADITIONAL)
ATTN: W.S.E.F. FERNANDO PHONE NO : 941 126 83964
400 DEANS ROAD SE DECISION MADE: 27-MAY-11
COLUMBO CE 10 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN
PHADIA AB 510(k) NO: K101251(TRADITIONAL)
ATTN: MARTIN MANN PHONE NO : 269 492 1957
4169 COMMERCIAL AVENUE SE DECISION MADE: 27-MAY-11
PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KONIX ULTRASOUND GEL
TURKUAZ SAGLIK HIZMETLERI MEDIKAL 510(k) NO: K101952(TRADITIONAL)
ATTN: MICHAEL SCOTT PHONE NO : 775 586 8700
88 MCFAUL WAY P.O. BOX 10321 SE DECISION MADE: 27-MAY-11
ZEPHYR COVE NV 89448 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECTVISION CATHETER, UNCOATED
PERCUVISION 510(k) NO: K110214(SPECIAL)
ATTN: FIDES MALDONADO PHONE NO : 508 231 8842
200 HOMER AVE, 2ND FLOOR SE DECISION MADE: 27-MAY-11
ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
VERTEBRAL TECHNOLOGIES, INC. 510(k) NO: K110226(SPECIAL)
ATTN: SURESH GHAI PHONE NO : 952 912 5400
5909 BAKER ROAD SUITE 550 SE DECISION MADE: 27-MAY-11
MINNETONKA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILJETR SYSTEM
DANVILLE MATERIALS INC. 510(k) NO: K110642(TRADITIONAL)
ATTN: LINDSAY TILTON PHONE NO : 925 973 0710
3420 FOSTORIA WAY ST. A-200 SE DECISION MADE: 27-MAY-11
SAN RAMON CA 94583 510(k) STATEMENT
DEVICE: 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP
ARTHROCARE CORP. 510(k) NO: K110781(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224
680 VAQUEROS AVE. SE DECISION MADE: 27-MAY-11
SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOINSIGHT
ULTRA MEDICAL DEVICES, INC. 510(k) NO: K110447(TRADITIONAL)
ATTN: PAUL KORTESOJA PHONE NO : 734 369 5100
3917 RESEARCH PARK DRIVE SUITE B7 SE DECISION MADE: 27-MAY-11
ANN ARBOR MI 48108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
ACCLARENT, INC. 510(k) NO: K110097(SPECIAL)
ATTN: KERI YEN PHONE NO : 650 687 5874
1525-B O'BRIEN DR. SE DECISION MADE: 27-MAY-11
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIMARA
VOCO GMBH 510(k) NO: K110589(TRADITIONAL)
ATTN: MANFRED T PLAUMANN PHONE NO : 494 721 7190
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 27-MAY-11
CUXHAVEN GM 27472 510(k) STATEMENT
DEVICE: 4CH FLEX SPEEDER
TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K111251(SPECIAL)
ATTN: PAUL BIGGINS PHONE NO : 714 669 7808
2441 MICHELLE DR SE DECISION MADE: 27-MAY-11
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K110641(TRADITIONAL)
ATTN: JOHN GORMLEY PHONE NO : 800 531 7963
940 CROSSROADS BLVD. SE DECISION MADE: 27-MAY-11
SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K111098(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 27-MAY-11
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K110785(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714 669 7808
2441 MICHELLE DR SE DECISION MADE: 27-MAY-11
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK REVISION HYBRID LINERS
MEDACTA INTERNATIONAL 510(k) NO: K111283(SPECIAL)
ATTN: ADAM GROSS PHONE NO : 805 437 7085
4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 27-MAY-11
CAMARILLO CA 91302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A
KINGTECH ENTERPRISE, LTD. 510(k) NO: K102935(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
FARM VILLAGE DALINGSHAN TOWN SE DECISION MADE: 27-MAY-11
DONGUAN CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEAK SUCTION COAGULATOR
PEAK SURGICAL, INC. 510(k) NO: K103775(TRADITIONAL)
ATTN: LOIS NAKAYAMA PHONE NO : 650 331 8920
2464 EMBARCADERO WAY SE DECISION MADE: 27-MAY-11
PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE IC-PRO SYSTEM
PAIEON, INC. 510(k) NO: K110256(TRADITIONAL)
ATTN: EREZ BEN-ZVI PHONE NO : 972 391 50000
23 HAMELACHA ST., P.O.B. 11355 SE DECISION MADE: 27-MAY-11
ROSH HAAYIN IS 48901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
SKANRAY TECHNOLOGIES 510(k) NO: K111330(TRADITIONAL)
ATTN: PARASURAMAPPA BELUR PHONE NO : 918 212 415559
PLOT 15-17 HEBBAL INDUSTRIAL AREA SE DECISION MADE: 27-MAY-11
MYSORE IN 570016 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HAIRMAX LASERCOMB
LEXINGTON INTERNATIONAL, LLC 510(k) NO: K110233(TRADITIONAL)
ATTN: CASPER E ULDRIKS ESQ. PHONE NO : 202 518 6385
1400 SIXTEENTH STREET, NW SUITE 40SE DECISION MADE: 27-MAY-11
WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K102049(SPECIAL)
ATTN: TELING HSU PHONE NO : 886 266 258188
3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 27-MAY-11
TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M4 MONITOR
SOPECTRUM MEDICAL LLP 510(k) NO: K110957(TRADITIONAL)
ATTN: STEVE TURNER PHONE NO : 440 124 2650121
HARRIER 4, METEOR BUSINESS PK CHELSE DECISION MADE: 31-MAY-11
GLOUCESTER UK GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K111295(SPECIAL)
ATTN: MARK MURPHY PHONE NO : 763 494 2377
ONE SCIMED PLACE SE DECISION MADE: 31-MAY-11
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORCETRIAD ELECTROSURGICAL GENERATOR
COVIDIEN LP, FORMERLY KNOW AS VALL510(k) NO: K110268(TRADITIONAL)
ATTN: DONALD HENTON PHONE NO : 303 530 6451
5920 LONGBOW DR. SE DECISION MADE: 31-MAY-11
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 251
TOTAL WITH SUMMARIES 233
TOTAL WITH STATEMENTS 18
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